Mitochondrial Function in the Peri-operative Setting: an Observational Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Southampton NHS Foundation Trust

About this trial

Complications after surgery are common and a burden for patients and health services. Therefore it is important that clinicians improve surgical outcomes. Mitochondria are the part of the body's cells that manage energy. Research has already shown that how our body's mitochondria behave can predict who survives in intensive care patients. The investigators think this could also predict who is more likely to develop complications after surgery. Therefore a study has been designed to find out if changes in mitochondria are related to postoperative complications. This will help doctors improve how they prepare patients for surgery and potentially how they manage their treatment, and result in improving outcomes for patients after surgery.

This study will recruit patients scheduled for major abdominal surgery as part of their treatment. The investigators will take samples of breath, blood and muscle to measure changes in mitochondria from the day before surgery to 7 days postoperatively. The muscle samples will only be taken when the patient is asleep having their operation. These samples will be used to analyse mitochondria. This study will be in two phases. Phase 1 is a pilot of up to 10 patients focussed on feasibility. Following this there will be an interim data analysis. The results may allow further optimisation to reduce the patient burden, eg reduction in sampling frequency, or avoiding need for muscle biopsy. The second phase will be a full cohort study of up to 40 patients, focussed on association of mitochondrial markers with clinical outcomes, such as postoperative complications, oxygen levels, pain, confusion and length of intensive care stay.

The results of this study could improve how doctors select and prepare patients for surgery. It may also affect how doctors manage their treatment during and after operations. This could result in reducing complications and illness burden for patients after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or above.

Having elective major abdominal surgery under general anaesthesia requiring a CVC and arterial line.

Planned for a Total Intravenous Anaesthesia (TIVA) technique +/- additional regional or neuraxial anaesthesia.

Admitted >6 hours prior to planned start of surgery as part of their normal care

Disqualifiers

Currently pregnant or up to 6 weeks post-partum

Participating in an interventional research study concerning intra-operative management already

Lacks capacity to give consent to participate in the study at time of recruitment

Currently in custody

Trial population

Adults having major elective abdominal surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational study: no interventions

    Other intervention

    Not applicable as observational study with no intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of eligible patients screened

Number of eligible patients screened

Time frame
Through study completion, an average of 3 years
2

Number of eligible patients consented

Number of eligible patients consented

Time frame
Through study completion, an average of 3 years
3

Postoperative Morbidity Survey (POMS) on day 7 postoperatively

Postoperative Morbidity Survey (POMS) on day 7 postoperatively

Time frame
From start of surgery to day 7 postoperatively

Secondary outcomes

1

Difference in mitochondrial activity in platelets as measured by high resolution respirometry from start of surgery to day 7 postoperatively

Difference in mitochondrial activity in platelets as measured by high resolution respirometry from start of surgery to day 7 postoperatively

Time frame
From start of surgery to day 7 post-operatively
2

Difference in mitochondrial function as measured by 13C-KICA breath test from day before surgery to day 7 postoperatively

Difference in mitochondrial function as measured by 13C-KICA breath test from day before surgery to day 7 postoperatively

Time frame
From day before surgery to day 7 post-operatively
3

Difference in mitochondrial activity in skeletal muscle as measured by high resolution respirometry from start of surgery to day 1 postoperatively

Difference in mitochondrial activity in skeletal muscle as measured by high resolution respirometry from start of surgery to day 1 postoperatively

Time frame
From start of surgery to day 1 post-operatively
4

Length of stay in ICU/HDU environment prior to ward step-down

Length of stay in ICU/HDU environment prior to ward step-down

Time frame
From start of surgery to day 7 post-operatively

Other outcomes

Sponsors and contacts

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University Hospital Southampton NHS Foundation Trust

Lead sponsor

University of Southampton

Collaborator

University of Cambridge

Collaborator

This trial is not recruiting at the moment. You can still explore other options: